U.S. patent application number 11/302654 was filed with the patent office on 2006-05-04 for surgical instrument.
This patent application is currently assigned to Cambridge Endoscopic Devices, Inc.. Invention is credited to Andres Chamorro, Woojin Lee.
Application Number | 20060095074 11/302654 |
Document ID | / |
Family ID | 37115660 |
Filed Date | 2006-05-04 |
United States Patent
Application |
20060095074 |
Kind Code |
A1 |
Lee; Woojin ; et
al. |
May 4, 2006 |
Surgical instrument
Abstract
The surgical instrument includes a distal tool, a rigid or
flexible elongated shaft that supports the distal tool, and a
proximal handle or control member, where the tool and the handle
are coupled to the respective distal and proximal ends of the
elongated shaft via distal and proximal bendable motion members.
Actuation means extends between said distal and proximal members
whereby any deflection of said control handle with respect to said
elongated instrument shaft causes a corresponding bending of said
distal motion member for control of said working member. A manually
rotatable member is arranged adjacent to the control handle for
manually rotating the instrument shaft and working member relative
to the control handle.
Inventors: |
Lee; Woojin; (Hopkinton,
MA) ; Chamorro; Andres; (Medford, MA) |
Correspondence
Address: |
David M. Driscoll, Esq.
1201 Canton Avenue
Milton
MA
02186
US
|
Assignee: |
Cambridge Endoscopic Devices,
Inc.
|
Family ID: |
37115660 |
Appl. No.: |
11/302654 |
Filed: |
December 14, 2005 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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10822081 |
Apr 12, 2004 |
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11302654 |
Dec 14, 2005 |
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11242642 |
Oct 3, 2005 |
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11302654 |
Dec 14, 2005 |
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60515560 |
Oct 30, 2003 |
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60671189 |
Apr 14, 2005 |
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Current U.S.
Class: |
606/205 |
Current CPC
Class: |
A61B 17/2909 20130101;
A61B 2017/2927 20130101; A61B 2017/2946 20130101; A61B 17/29
20130101; A61B 2017/2902 20130101; A61B 2017/2929 20130101; A61B
2017/291 20130101 |
Class at
Publication: |
606/205 |
International
Class: |
A61B 17/28 20060101
A61B017/28 |
Claims
1. A surgical instrument comprising: an elongated instrument shaft
having proximal and distal ends; a tool disposed from the distal
end of the instrument shaft and supported extending along a distal
tool axis; a control handle disposed from the proximal end of the
instrument shaft; a distal bendable member for coupling the distal
end of said elongated instrument shaft to said tool; a proximal
bendable member for coupling the proximal end of said elongated
instrument shaft to said handle; actuation means extending between
said distal and proximal bendable members for coupling motion of
said proximal motion member to said distal motion member for
controlling the positioning of said tool; and a rotation knob
adjacent the control handle and rotatable relative to the control
handle for causing a corresponding rotation of the tool about said
distal tool axis.
2. The surgical instrument of claim 1 wherein said proximal
bendable member supports said rotation knob so that any rotation
imparted to said knob causes a corresponding rotation of said
proximal bendable member.
3. The surgical instrument of claim 2 wherein said knob has a
cavity for receiving at least a portion of said proximal bendable
member.
4. The surgical instrument of claim 1 wherein said proximal
bendable member is bendable into a curved configuration and is
fixedly secured with said rotation knob.
5. The surgical instrument of claim 1 wherein both said bendable
members are bendable into a curved configuration and any rotation
of said rotation knob causes a corresponding rotation of said
bendable members, instrument shaft and tool.
6. For a manually operated medical instrument having an instrument
shaft that couples with an operating handle at a proximal end
thereof and a tool at a distal end thereof, further comprising a
proximal bendable member at the proximal end of the instrument
shaft that is bendable into a curved configuration, a distal
bendable member at the distal end of the instrument shaft that is
bendable into a curved configuration, and one or more actuating
elements intercoupling the proximal and distal bendable members
responsive to a manually initiated bending at the proximal bendable
member to cause a corresponding bending into a curved configuration
of the distal bendable member so as to control, via the handle, the
positioning of the tool.
7. The instrument of claim 6 wherein the bendable members are
bendable in all directions.
8. The instrument of claim 6 wherein the bendable members are
bendable in any direction.
9. The instrument of claim 6 wherein the proximal bendable member
is manipulated in any direction do that the distal bendable member
is controlled in three dimensions.
10. The instrument of claim 6 further including a rotation knob
disposed between said handle and proximal bendable member.
11. The instrument of claim 10 wherein said rotation knob is
supported to rotate the proximal bendable member therewith.
12. The instrument of claim 11 wherein rotation of the rotation
knob controls the tool for corresponding rotation about a tool
axis.
13. The instrument of claim 11 wherein said tool is disposed from
said distal bendable member along a longitudinal distal tool axis,
the rotation of said rotation knob causing a corresponding rotation
of said tool about said distal tool axis.
14. The instrument of claim 11 wherein said one or more actuating
elements comprises a set of actuation cables and wherein at least
one of said set is in tension while at least another one thereof is
in relaxation.
15. The instrument of claim 14 including four cables disposed at 90
degree intervals about the instrument shaft with two in tension and
two in relaxation during a bending.
16. The instrument of claim 10 wherein the instrument shaft
comprises an elongated instrument shaft extending along a
longitudinal axis and wherein the distal bendable member is
disposed in-line with the elongated instrument shaft coupling a
distal end of said elongated instrument shaft to said tool and
wherein the proximal bendable member is disposed in line with the
elongated instrument shaft coupling a proximal end of said
elongated instrument shaft via said rotation knob to said
handle.
17. A surgical instrument comprising: an elongated instrument shaft
having proximal and distal ends; a working member disposed from the
distal end of the instrument shaft; and a control handle disposed
from the proximal end of the instrument shaft; a distal bendable
member capable of bending into a curved configuration; said working
member being coupled to the distal end of said elongated instrument
shaft via said distal bendable member; a proximal bendable member
capable of bending into a curved configuration; said control handle
coupled to the proximal end of said elongated instrument shaft via
a proximal bendable member; a manually rotatable member arranged
adjacent the control handle and between the control handle and
proximal bendable member; said rotatable member adapted to be
manually rotated to, in turn, rotate the instrument shaft, distal
bendable member and working member relative to said control handle;
and an actuation element extending between said distal and proximal
bendable members whereby any deflection of said control handle with
respect to said elongated instrument shaft causes a corresponding
bending of said distal motion member for control of said working
member;
18. The surgical instrument of claim 17 wherein said rotatable
member comprises a rotation knob having a cavity for receiving at
least a portion of said proximal bendable member therein and at
least a portion of said rotation knob is received by said handle in
an open end of said handle, said rotation knob having said proximal
bendable member supported therein and in a fixed relative rotation
with respect to said proximal bendable member.
19. The surgical instrument of claim 17 wherein said working member
comprises a tool that is supported from said distal bendable member
extending along a distal tool axis and said rotatable member
comprises a rotation knob, the rotation of said rotation knob
causing a rotation of said working member about said distal tool
axis.
20. The surgical instrument of claim 19 wherein the rotation of
said rotation knob rotates the instrument shaft and distal bendable
member, rotating the tool about the distal tool axis while
maintaining the orientation of the tool.
Description
RELATED APPLICATIONS
[0001] The present invention is a continuation-in-part of earlier
filed U.S. application Ser. No. 10/822,081, filed on Apr. 12, 2004
which, in turn, claims priority to U.S. Provisional Application
Ser. No. 60/515,560, filed on Oct. 30, 2003. The present
application also claims priority to earlier filed U.S. Provisional
Application 60/671,189, filed on Apr. 14, 2005. This application is
also a continuation of earlier filed U.S. application Ser. No.
11/242,642, filed on Oct. 3, 2005. The content of all of the
aforementioned applications are hereby incorporated by reference
herein in their entirety.
TECHNICAL FIELD
[0002] The present invention relates in general to surgical
instruments, and more particularly to manually-operated surgical
instruments that are intended for use in minimally invasive surgery
or other forms of surgical procedures or techniques. The instrument
described herein is for a laparoscopic procedure, however, it is to
be understood that the instrument of the present invention can be
used for a wide variety of other procedures, including intraluminal
procedures.
BACKGROUND OF THE INVENTION
[0003] Endoscopic and laparoscopic instruments currently available
in the market are extremely difficult to learn to operate and use,
mainly due to a lack of dexterity in their use. For instance, when
using a typical laparoscopic instrument during surgery, the
orientation of the tool of the instrument is solely dictated by the
locations of the target and the incision. These instruments
generally function with a fulcrum effect using the patients own
incision area as the fulcrum. As a result, common tasks such as
suturing, knotting and fine dissection have become challenging to
master. Various laparoscopic instruments have been developed over
the years to overcome this deficiency, usually by providing an
extra articulation often controlled by a separately disposed
control member for added control. However, even so these
instruments still do not provide enough dexterity to allow the
surgeon to perform common tasks such as suturing, particularly at
any arbitrarily selected orientation.
[0004] Accordingly, an object of the present invention is to
provide an improved laparoscopic or endoscopic surgical instrument
that allows the surgeon to manipulate the tool end of the surgical
instrument with greater dexterity.
[0005] Another object of the present invention is to provide an
improved surgical instrument that has a wide variety of
applications, through incisions, through natural body orifices or
intraluminally.
SUMMARY OF THE INVENTION
[0006] To accomplish the foregoing and other objects and features
of this invention, there is provided a surgical instrument that
includes an elongated instrument shaft having proximal and distal
ends; a working member disposed at the distal end of the instrument
shaft; and a control handle disposed at the proximal end of the
instrument shaft. The working member is coupled to the distal end
of the elongated instrument shaft via a distal motion member, while
the control handle is coupled to the proximal end of the elongated
instrument shaft via a proximal bendable member. Actuation means
extends between the distal and proximal motion members whereby any
deflection of the control handle with respect to the elongated
instrument shaft causes a corresponding bending of the distal
motion member for control of the working member. A manually
rotatable member is arranged adjacent the control handle for
manually rotating the instrument shaft and working member about
their own axes.
[0007] In accordance with other aspects of the present invention
the actuation means is constructed and arranged so that a motion of
the handle causes a like direction motion of the working member, or
alternatively the actuation means is constructed and arranged so
that a motion of the handle causes an opposite direction motion of
the working member. The distal motion member may comprise a distal
bendable member and the proximal bendable member is moveable in any
direction. The handle may comprise a handle housing and the
manually rotatable member may comprise a rotation knob disposed at
an open end of the housing. A portion of the proximal bendable
member may be disposed in the rotation knob.
[0008] In accordance with still other aspects of the present
invention, the proximal bendable member may comprise a unitary
slotted structure having a plurality of discs separated by slots.
The surgical instrument may also include an actuation lever
pivotally supported from the handle and an actuator cable
intercoupled between the actuation lever and working member. The
surgical instrument may also include a ratchet and pawl arrangement
coupled to the lever, a slider within a housing of the handle, a
link for intercoupling the lever and slider and a release button
intercoupled to the ratchet. A pair of springs is provided, one
supported in the slider and coupled to the link and the other
disposed between the slider and the handle housing.
[0009] In accordance with further aspects of the present invention
the surgical instrument comprises an elongated instrument shaft
having proximal and distal ends; a working member coupled from the
distal end of the instrument shaft; a control handle disposed at
the proximal end of the instrument shaft; a distal motion means at
the distal end of the instrument shaft; a proximal motion means at
the proximal end of the instrument shaft; actuation means extending
between the distal and proximal means whereby any deflection of the
control handle with respect to the elongated instrument shaft
causes a corresponding motion of the distal motion means for
control of the working member; and means for manually rotating the
instrument shaft and working member relative to the control
handle.
[0010] In accordance with still further aspects of the present
invention the distal motion means comprises a distal bendable
member and the proximal motion means comprises a proximal bendable
member that is moveable in any direction. The handle comprises a
handle housing and said means for manually rotating comprises a
rotation knob disposed at an open end of the housing. A portion of
the proximal bendable member is disposed in a hollow of the
rotation knob. The proximal bendable member comprises a unitary
slotted structure having a plurality of discs separated by slots
and further including a plurality of ribs interconnecting adjacent
discs, said ribs being disposed at intervals about the member of 90
degrees or less.
[0011] In accordance with another aspect of the present invention
there is provided a surgical instrument comprising, an elongated
instrument shaft having proximal and distal ends; a working member
disposed at the distal end of the instrument shaft; and a control
handle disposed at the proximal end of the instrument shaft. The
working member is coupled to the distal end of the elongated
instrument shaft via a distal motion member while the control
handle is coupled to the proximal end of the elongated instrument
shaft via a proximal bendable member. Actuation means extends
between the distal and proximal members whereby any deflection of
the control handle with respect to the elongated instrument shaft
causes a corresponding bending of the distal motion member for
control of the working member. At least the proximal bendable
member may comprise a unitary slotted structure having a plurality
of discs separated by slots.
[0012] In accordance with another aspect of the present invention
the distal motion member also comprises a bendable member formed as
a unitary slotted structure having a plurality of discs separated
by slots; the proximal bendable member includes a plurality of ribs
interconnecting adjacent discs, said ribs being disposed at
intervals about the member of less than 90 degrees. The ribs are
disposed at an interval on the order of 60 degrees; and further
including a manually rotatable member arranged adjacent the control
handle for manually rotating the instrument shaft and working
member relative to the control handle and about their own axes.
[0013] A further embodiment of the invention is a surgical
instrument comprising, an elongated instrument shaft having
proximal and distal ends; a tool disposed from the distal end of
the instrument shaft and supported extending along a distal tool
axis; a control handle disposed from the proximal end of the
instrument shaft; a distal bendable member for coupling the distal
end of said elongated instrument shaft to the tool; a proximal
bendable member for coupling the proximal end of the elongated
instrument shaft to the handle; actuation means extending between
said distal and proximal bendable members for coupling motion of
the proximal motion member to said distal motion member for
controlling the positioning of the tool; and a rotation knob
adjacent the control handle and rotatable relative to the control
handle for causing a corresponding rotation of the tool about the
distal tool axis.
[0014] In accordance with other aspects of the present invention
the proximal bendable member may support the rotation knob so that
any rotation imparted to the knob causes a corresponding rotation
of the proximal bendable member; the knob may have a cavity for
receiving at least a portion of the proximal bendable member; the
proximal bendable member may be bendable into a curved
configuration and is be fixedly secured with the rotation knob;
both the bendable members may be bendable into a curved
configuration and any rotation of the rotation knob causes a
corresponding rotation of the bendable members, instrument shaft
and tool.
[0015] Another embodiment of the invention is a manually operated
medical instrument having an instrument shaft that couples with an
operating handle at a proximal end thereof and a tool at a distal
end thereof. The instrument further comprises a proximal bendable
member at the proximal end of the instrument shaft that is bendable
into a curved configuration, a distal bendable member at the distal
end of the instrument shaft that is bendable into a curved
configuration, and one or more actuating elements intercoupling the
proximal and distal bendable members responsive to a manually
initiated bending at the proximal bendable member to cause a
corresponding bending into a curved configuration of the distal
bendable member so as to control, via the handle, the positioning
of the tool.
[0016] In accordance with still other aspects of the present
invention the bendable members may be bendable in all directions;
the bendable members may be bendable in any direction; the proximal
bendable member may be manipulated in any direction do that the
distal bendable member is controlled in three dimensions; a
rotation knob may be disposed between the handle and proximal
bendable member; the rotation knob may be supported to rotate the
proximal bendable member therewith; the rotation of the rotation
knob controls the tool for corresponding rotation about a tool
axis; the tool may be disposed from the distal bendable member
along a longitudinal distal tool axis, the rotation of the rotation
knob causing a corresponding rotation of the tool about the distal
tool axis; one or more actuating elements comprises a set of
actuation cables and wherein at least one of the set is in tension
while at least another one thereof is in relaxation; four cables
may be disposed at 90 degree intervals about the instrument shaft
with two in tension and two in relaxation during a bending and
wherein the instrument shaft comprises an elongated instrument
shaft extending along a longitudinal axis and wherein the distal
bendable member is disposed in-line with the elongated instrument
shaft coupling a distal end of the elongated instrument shaft to
the tool and wherein the proximal bendable member is disposed in
line with the elongated instrument shaft coupling a proximal end of
the elongated instrument shaft via the rotation knob to the
handle.
[0017] Another embodiment of the invention is a surgical instrument
comprising: an elongated instrument shaft having proximal and
distal ends; a working member disposed from the distal end of the
instrument shaft; and a control handle disposed from the proximal
end of the instrument shaft. A distal bendable member is capable of
bending into a curved configuration, the working member being
coupled to the distal end of the elongated instrument shaft via the
distal bendable member; a proximal bendable member is capable of
bending into a curved configuration, the control handle coupled to
the proximal end of the elongated instrument shaft via a proximal
bendable member. A manually rotatable member is arranged adjacent
the control handle and between the control handle and proximal
bendable member. The rotatable member is adapted to be manually
rotated to, in turn, rotate the instrument shaft, distal bendable
member and working member relative to the control handle. An
actuation element extends between the distal and proximal bendable
members whereby any deflection of the control handle with respect
to the elongated instrument shaft causes a corresponding bending of
the distal motion member for control of the working member.
[0018] In accordance with other aspects of the present invention
the rotatable member comprises a rotation knob having a cavity for
receiving at least a portion of the proximal bendable member
therein and at least a portion of the rotation knob is received by
the handle in an open end of the handle, the rotation knob having
the proximal bendable member supported therein and in a fixed
relative rotation with respect to the proximal bendable member. The
working member may comprise a tool that is supported from the
distal bendable member extending along a distal tool axis and the
rotatable member may comprise a rotation knob, the rotation of the
rotation knob causing a rotation of the working member about the
distal tool axis. The rotation of the rotation knob rotates the
instrument shaft and distal bendable member, rotating the tool
about the distal tool axis while maintaining the orientation of the
tool.
BRIEF DESCRIPTION OF THE DRAWINGS
[0019] It should be understood that the drawings are provided for
the purpose of illustration only and are not intended to define the
limits of the disclosure. The foregoing and other objects and
advantages of the embodiments described herein will become apparent
with reference to the following detailed description when taken in
conjunction with the accompanying drawings in which:
[0020] FIG. 1 is a perspective view of a preferred embodiment of
the surgical instrument of the present invention;
[0021] FIGS. 2a, 2b and 2c are sequential side views of one
embodiment of the surgical instrument wherein the distal bendable
member bends in the same direction as the proximal bendable
member;
[0022] FIGS. 3a, 3b and 3c are sequential side views of another
embodiment of the surgical instrument wherein the distal bendable
member bends in the opposite direction to the proximal bendable
member;
[0023] FIG. 4 is a schematic side view of the surgical instrument
depicted in FIGS. 1-3 illustrating the instrument extending through
an incision and adapted to be controlled by a surgeon to roll the
instrument tool about its longitudinal or Z axis;
[0024] FIG. 5 is a longitudinal cross-sectional side view of the
surgical instrument of FIG. 1 with a handle position corresponding
to the jaws being in a fully open position;
[0025] FIG. 6 is a longitudinal cross-sectional side view as
depicted in FIG. 5 further illustrating the jaws being closed upon
a needle;
[0026] FIG. 7 is a fragmentary cross-sectional view of the handle
assembly of the surgical instrument of FIG. 1 and further
illustrating the jaw actuation means exerting a pressure at the
jaws;
[0027] FIG. 8 is a cross-sectional plan view taken along line 8-8
of FIG. 6 and illustrating the jaw actuation means exerting a
pressure on the jaws;
[0028] FIG. 9 is a cross-sectional view taken along line 9-9 of
FIG. 6 showing the camming means for the moveable jaw;
[0029] FIG. 10 is a cross-sectional view taken along line 10-10 of
FIG. 6 showing the flex cable anchors;
[0030] FIG. 11 is a cross-sectional view taken along line 11-11 of
FIG. 6 showing the distal flexible or bendable member and cables
passing therethrough;
[0031] FIG. 12 is a cross-sectional view taken along line 12-12 of
FIG. 6 showing the instrument shaft portion of the instrument and
cables passing therethrough;
[0032] FIG. 13 is a cross-sectional view taken along line 13-13 of
FIG. 6 showing the cable transition from the instrument shaft to
the proximal bendable member;
[0033] FIG. 14 is a cross-sectional view taken along line 14-14 of
FIG. 6 showing further details of the proximal bendable member and
cable passages;
[0034] FIG. 15 is a cross-sectional view taken along line 15-15 of
FIG. 6 showing the proximal end of the rotation member or knob;
[0035] FIG. 16 is a cross-sectional view taken along line 16-16 of
FIG. 6 showing the ratchet and pawl locking action for the spring
tensioning of the tool actuator cable;
[0036] FIG. 17 is a cross-sectional view taken along line 17-17 of
FIG. 6 showing the rotating barrel means to prevent torsional
forces on the tool actuator cable;
[0037] FIG. 18 is a cross-sectional view taken along line 18-18 of
FIG. 6 showing the spring loading means for the tool actuator
cable;
[0038] FIG. 19 is an exploded perspective view illustrating further
details of the surgical instrument depicted in FIG. 1, particularly
at the handle assembly;
[0039] FIG. 20 is a somewhat enlarged cross-sectional view of the
distal end of the surgical instrument as taken along line 20-20 of
FIG. 19;
[0040] FIG. 21 is an exploded perspective view of the distal end of
the surgical instrument as shown in FIG. 20;
[0041] FIG. 22 is a schematic side cross-sectional view of the
instrument type described in FIGS. 3a-3c including the cabling and
actuation;
[0042] FIG. 23 is a schematic perspective view illustrating the
cabling of FIG. 22;
[0043] FIG. 24 is a schematic perspective view of an alternate
cabling scheme such as used in the embodiment of FIGS. 2a-2c;
and
[0044] FIGS. 25-28 are sequential perspective schematic views
illustrating the cable arrangement for different rotational
positions.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0045] The instrument of the present invention may be used to
perform minimally invasive procedures. "Minimally invasive
procedure," refers herein to a surgical procedure in which a
surgeon operates through small cut or incision, the small incision
being used to access the operative site. In one embodiment, the
incision length ranges from 1 mm to 20 mm in diameter, preferably
from 5 mm to 10 mm in diameter. This procedure contrasts those
procedures requiring a large cut to access the operative site.
Thus, the flexible instrument is preferably used for insertion
through such small incisions and/or through a natural body lumen or
cavity, so as to locate the instrument at an internal target site
for a particular surgical or medical procedure. The introduction of
the surgical instrument into the anatomy may also be by
percutaneous or surgical access to a lumen or vessel, or by
introduction through a natural orifice in the anatomy.
[0046] In addition to use in a laparoscopic procedure, the
instrument of the present invention may be used in a variety of
other medical or surgical procedures including, but not limited to,
colonoscopic, upper GI, arthroscopic, sinus, thorasic, transvaginal
and cardiac procedures. Depending upon the particular procedure,
the instrument shaft may be rigid, semi-rigid or flexible.
[0047] Although reference is made herein to a "surgical
instrument," it is contemplated that the principles of this
invention also apply to other medical instruments, not necessarily
for surgery, and including, but not limited to, such other
implements as catheters, as well as diagnostic and therapeutic
instruments and implements.
[0048] FIG. 1 is a perspective view of a preferred embodiment of
the surgical instrument 10 of the present invention. In this
surgical instrument both the tool and handle motion members or
bendable members are capable of bending in any direction, thus
enabling three dimensional tool positioning. They are
interconnected via cables in such a way that a bending action at
the proximal member provides a related bending at the distal
member. As will be described in further detail hereinafter, the
proximal member is preferably larger than the distal member so as
to provide enhanced ergonomic control. FIGS. 2a-2c show a bending
action in which the distal bendable member bends in the same
direction as the proximal bendable member. FIGS. 3a-3c show an
alternate embodiment in which the bendable or flexible members are
adapted to bend in opposite directions. FIG. 23 is a schematic
perspective view illustrating the cabling that corresponds to the
action depicted in FIGS. 3a-3c. FIG. 24 is a schematic perspective
view illustrating the cabling that corresponds to the action
depicted in FIGS. 2a-2c.
[0049] It should be noted that the amount of bending motion
produced at the distal bending member is determined by the
dimension of the proximal bendable member in comparison to that of
the distal bendable member. In the disclosed embodiment the
proximal bendable member is approximately three times the diameter
of the distal bendable member, and as a result, the motion produced
at the distal bendable member is about three times the magnitude of
the motion at the proximal bendable member. Although FIGS. 2 and 3
show only the side view where only pitch motion is illustrated, it
should be noted that the proximal bendable member can be bent in
any direction controlling the distal bendable member to bend in
either the same or an opposite direction, but in the same plane. As
a result, as depicted in FIG. 4 the surgeon is able to roll the
instrument's tool about its longitudinal axis at any orientation
simply by rolling the axial rotation knob 24.
[0050] In this description reference is made to bendable members.
These members may also be referred to as turnable members or
flexible members. In the descriptions set out herein, terms such as
"bendable section," "bendable segment," "bendable motion member,"
or "turnable member" refer to an element of the instrument that is
controllably bendable in comparison to an element that is pivoted
at a joint. The bendable elements of the present invention enable
the fabrication of an instrument that can bend in any direction
without any singularity and that is further characterized by a
ready capability to bend in any direction, all with a single
unitary or uni-body structure. A definition of these bendable
motion members is--an instrument element, formed either as a
controlling means or a controlled means, and that is capable of
being constrained by tension or compression forces to deviate from
a straight line to a curved configuration without any sharp breaks
or angularity.
[0051] Referring to FIG. 1, the surgical instrument 10 is comprised
of a handle 12 at the proximal end of the instrument, an elongated
instrument shaft 14 and a tool or end effector 16 disposed at the
distal end of the surgical instrument. In the disclosed embodiment
the instrument shaft 14 is rigid, usually of a metal material,
although it may also be constructed so as to be at least partially
flexible or bendable. For normal laparoscopic procedures the
instrument shaft 14 is usually rigid. For an example of a flexible
instrument shaft used intraluminally refer herein to FIGS. 14 and
15 of related U.S. application Ser. No. 10/822,081, filed on Apr.
12, 2004 which is hereby incorporated by reference herein in its
entirety.
[0052] In FIG. 1 the handle 12 is illustrated as comprised of two
handle halves 12A and 12B. A lever 22 is manipulatable by the
surgeon for opening and closing the end effector 16 at the distal
end of the instrument shaft 14. In FIG. 1 the end effector is
illustrated as comprised of a movable jaw 44 and a fixed jaw 46.
The rotation knob 24 at the proximal end of the instrument is used
to rotate the entire instrument shaft and end effector. This
rotation is illustrated in FIG. 1 by the circular arrow R. Also
note in FIG. 1 the illustration of a coordinate system expressed by
the X-Y-Z axes. The roll of the instrument indicated by the arrow R
is about the Z axis. The Z axis corresponds to the longitudinal
axis of the shaft 14 of the instrument 10. FIG. 1 also illustrates
an adaptor cover 26 for partially retaining a portion of the
proximal bendable member 18. At the distal end of the instrument
shaft 14, there is provided the distal bendable member 20. In FIG.
1 this is illustrated at least partially covered by the cover 98.
The cover 98 may be a thin plastic or rubber flexible tube that
readily deflects as the distal bendable member is actuated from the
proximal bendable member. For instruments such as a needle holder
or a suture assist device, the compliant cover 98 is beneficial in
preventing the suture from catching while tying a knot. However,
for other applications one may choose not to use the cover 98 so as
to simplify the instrument and its fabrication. Other components,
such as the knob 24, cover 26 and bendable members are formed of a
plastic material.
[0053] The instrument of the present invention is preferably
constructed to be disposable or alternatively resposable.
Accordingly, to make the instrument as inexpensively as possible
most of the components are made of a plastic material.
[0054] FIGS. 2a-2c depict one embodiment for the surgical
instrument in which the handle and end effector are controlled to
turn or bend in the same direction. If the handle is turned
upwardly then the tool turns upwardly and vice-versa. FIG. 2a shows
the handle in a straight position and the corresponding tool in a
likewise straight position. FIG. 2b illustrates the handle end of
the instrument having been moved upwardly in the direction of arrow
A. This causes a corresponding movement upwardly of the end
effector 16 in the direction of arrow B. Similarly, FIG. 2c
illustrates the handle 12 being moved downwardly in the direction
of arrow C causing a corresponding movement downwardly of the end
effector 16 in the direction of arrow D. The bending forces
depicted in FIGS. 2b and 2c are imposed upon the proximal bendable
member 18 and when that is bent or turned, this causes a
corresponding bending or turning of the distal bendable member so
as to orient the end effector. The bending forces are imposed at
the handle of the instrument by the surgeon. Also, although FIGS.
2a-2c only depict "up" and "down" movement essentially in the plane
of the paper, it is understood that the handle can be actuated in
any direction including planes in and out of the paper.
[0055] FIGS. 3a-3c depict a different embodiment of the surgical
instrument. In this embodiment, the bending of the handle portion
of the instrument causes an opposite direction bending of the end
effector. In FIG. 3a the handle is shown in a straight position and
the end effector is also shown in a straight position. In FIG. 3b
the handle 12 has been moved upwardly in the direction of arrow E
causing a corresponding movement downwardly of the end effector 16
in the direction of arrow F. In FIG. 3c the handle 12 is shown
being bent or turned to a downward position as illustrated by the
arrow G. This causes a corresponding bending or turning up of the
end effector 16 in the direction depicted by arrow H.
[0056] As with the embodiment of FIGS. 2a-2c, in the FIGS. 3a-3c
the translation of the bending force at the handle end of the
instrument is transferred to the distal end of the instrument. This
occurs by way of the proximal bendable member 18 controlled by the
user from the handle 12 and, in turn, controlling the distal
bendable member 12 which, in turn, controls the positioning and
orientation of the end effector 16. Also, although FIGS. 3a-3c only
depict "up" and "down" movement essentially in the plane of the
paper, it is understood that the handle can be actuated in any
direction including planes in and out of the paper.
[0057] FIG. 4 depicts the surgical instrument 10 in position, as
may occur during a surgical procedure. For example, the instrument
may be used for laparoscopic surgery through the abdominal wall 4.
For this purpose there is provided an insertion site 6 at which
there is disposed a cannula or trocar 8. The shaft of the
instrument 14 is adapted to pass through the cannula 8 so as to
dispose the distal end of the instrument at an operative site. The
end effector 16 is depicted in FIG. 4 at such an operative site.
FIG. 4 also depicts the rolling motion that can be carried out with
the instrument of the present invention. This can occur by virtue
of the rotation of the rotation knob 24 relative to the handle 12.
This is illustrated in FIG. 4 by the circular arrow R1. When the
rotation knob 24 is rotated, in either direction, this causes a
corresponding rotation of the instrument shaft 14. This is depicted
in FIG. 4 by the rotational arrow R2. This same motion also causes
a rotation of the end effector 16 as illustrated by the rotational
arrow R3 in FIG. 4.
[0058] The combination of manipulation via the bendable members and
the rotation via the knob 24 provides a very precise and
ergonomically comfortable degree of control for the surgeon. The
instrument is adapted to be held in a number of different ways in
use. In one technique, the instrument handle may be grasped so that
the middle, ring and small fingers are about the surface 12C while
the thumb engages the lever 22 and release button 96. The index
finger may extend to engage the rotation knob 24. In this way all
manipulations can be easily coordinated by the surgeon with one
hand. The instrument may also be grasped in the following manner.
The thumb may rest on the surface 12C while the fingers grasp the
lever 22. The index finger may manipulate the knob 24. The thumb
may also assist in manipulating the knob 24.
[0059] In the drawings a set of jaws is depicted, however, other
tools or devices may be readily adapted for use with the instrument
of the present invention. These include, but are not limited to,
cameras, detectors, optics, scope, fluid delivery devices,
syringes, etc. The tool may include a variety of articulated tools
such as: jaws, scissors, graspers, needle holders, micro
dissectors, staple appliers, tackers, suction irrigation tools and
clip appliers. In addition, the tool may include a non-articulated
tool such as: a cutting blade, probe, irrigator, catheter or
suction orifice.
[0060] Reference is now made to FIGS. 5-22 for further details of
the instrument 10 depicted in FIG. 1. The instrument that is
depicted in FIGS. 5-22 is the embodiment illustrated in FIGS.
3a-3c. In this particular embodiment the cabling within the
instrument shaft is maintained in a straight configuration such as
illustrated in FIG. 23. Alternate cabling is described in FIG. 24
corresponding to the embodiment of FIGS. 2a-2c.
[0061] As indicated previously, the end effector or tool 16 is
actuated by means of the jaw actuation means 30 which is comprised
primarily of the elongated lever 22. The lever 22 is supported from
the housing at the lever pivot pin 23. Refer to FIGS. 5-7 and 19.
The closing of the lever 22 against the handle 12 acts upon the
slider 28 which is used to capture the very proximal end of the
actuation cable 38. When the slider 28 is in the position depicted
in FIG. 5, it is noted that the end effector jaws are fully open.
When the slider is moved toward the right as depicted in FIG. 6,
then the jaws 44 and 46 are moved toward a closed position. In FIG.
6 the jaws are illustrated as closing so as to grasp a needle
45.
[0062] The instrument shaft 14 includes an outer shaft tube 32 that
may be constructed of a light weight metal material or may be a
plastic material. The proximal end of the tube 32 is received by
the adaptor cover 26. The distal end of the tube 32 is secured to
the distal bendable member 20. Refer to FIG. 21 for some further
details of the distal bendable member 20. Within the outer shaft
tube 32 there is provided a support tube 34 that is preferably
constructed of a plastic material. Tube 34 extends between the
distal bendable or flexible member 20 and the proximal bendable or
flexible member 18. The jaw actuator cable 38 extends within this
support tube 34. The support tube 34, as depicted in FIG. 21,
supports along its length a plurality of spacers 36. There may be
five spacers disposed along the support tube 34. In the schematic
diagram of FIG. 23 less than five are shown so as to simplify the
diagram. Each of the spacers 36 is preferably evenly spaced and
each is provided with diametric guide slots 37. In the embodiment
disclosed herein there are four such guide slots disposed at 90
degree intervals about each spacer 36.
[0063] Refer also now to FIG. 21 for further details of the tool
end of the instrument. The end effector 16 is comprised of a pair
of jaws 44 and 46. As indicated previously these jaws may be used
to grasp a needle 45 or other item. The upper jaw 44 fits within a
channel 47 in the lower jaw 46. A pivot pin 48 is used between the
jaws to enable rotation therebetween. A translation pin 42 extends
through the slot 50 of jaw 46 and the slot 52 of jaw 44 and engages
with the hole in the distal cable end connector 40. The connector
40 is secured to the very distal end of the jaw actuator cable 38
and is positioned within the channel 49 of the jaw 44. When the
lever 22 is in its rest position, as depicted in FIG. 5, the jaws
are fully open. In that position the pin 42 is at a more distal
location maintaining the jaw in an open position. As the cable 38
is pulled, such as to the right in FIG. 6, then the pin 42 moves to
the right in the slots 50 and 52 causing the jaws 44 and 46 to
pivot toward a closed position as depicted in FIG. 6.
[0064] FIG. 21 also depicts an end wall 54 of the jaw 46. One end
of the distal bendable member 20 is urged against this end wall 54.
The member 20 may be secured to the wall 54 by an appropriate
means. In the disclosed embodiment, the cabling tension itself of
the instrument holds the members together. On the end wall 54 there
are disposed a pair of anchors 56 and 58 for the flex control
cables 100. FIG. 21 illustrates four such cables 100a, 100b, 100c
and 100d. The distal end of the distal bendable member 20 is
provided with pockets 59 for receiving the anchors 56 and 58. In
this regard refer also to the cross-sectional view of FIG. 20 for
an illustration of the position of the anchors 56 and 58. The
anchors 56 and 58 are firmly attached to the end wall 54. FIG. 20
also illustrates the jaws closed with the translation pin 42 at the
right end of the slots 50 and 52.
[0065] The jaw actuator cable 38 terminates at its respective ends
at the end effector and the rotation barrel 66 (see FIG. 6). Within
each of the bendable sections or bendable members 18 and 20 there
is provided a plastic tube. This includes a distal tube 60 and a
proximal tube 62. Both of these tubes may be constructed of a
plastic such as polyethyletherkeytone (PEEK). The material of the
tubes 60 and 62 is sufficiently rigid to retain the cable 38 and
yet is flexible enough so that it can readily bend with the bending
of the bendable members 18 and 20. The tubes have a sufficient
strength to receive and guide the cable, yet are flexible enough so
that they will not kink or distort, and thus keep the cable in a
proper state for activation, and also defines a fixed length for
the cable. The tubes 60 and 62 are longitudinally stiff, but
laterally flexible.
[0066] FIG. 7 illustrates the proximal tube 62 extending within the
proximal bendable member 18 between the support tube 34 and the
rotation shaft 64. The jaw actuator cable 38 also extends through
the rotation shaft 64. Refer also to FIG. 19 for an illustration of
the rotational shaft 64. At either end of the shaft 64 is an E-ring
65 for securing the rotational shaft 64 in place. FIG. 19
illustrates the shaft 64 extending from the rotational knob 24 and
the handle halves 12A and 12B that wrap around a part of the
rotation knob 24. The opposite end E-rings 65 engage respectively
with the handle and rotational knob and retain the rotational knob
24 in place relative to the handle 12, which, in turn, then retains
the proximal bendable member in place relative to the handle. FIG.
7 shows the E-ring 65 on the left being disposed between an
interior cavity of the knob 24 and a cavity in the proximal
bendable member 18. The E-ring 65 on the right in FIG. 7 is
captured by the handle 12.
[0067] The control of the end effector 16 is by means of the jaw
actuator cable 38. The very proximal end of the jaw actuator cable
38 is retained in the rotational barrel 66. As illustrated, for
example, in FIG. 7 the cable 38 is secured to the rotational barrel
by means of a pair of set screws 67. The rotational barrel 66 is
supported within the slider 28. More particularly, the rotational
barrel 66 is disposed within the slider pocket 68. Refer also to
FIG. 19 for an illustration of the barrel 66 and pocket 68. The
slider 28 is also provided with a slot 69 that extends from the
pocket 68 and accommodates the link 70. The link 70 is the main
means for actuating the slider 28 and, in turn, the actuator cable
38 from the lever 22.
[0068] The actuation link 70 is supported at one end from the lever
22 by means of the pivot pin 71. The pivot pin 71 is disposed
within a slot of the lever 22 as is depicted in FIG. 19. The
opposite end of the link 70 is supported at another pin, referred
to herein as slider pin 72. The pin 72 is retained for longitudinal
movement in the slot 74 in the slider 28. FIG. 7 shows the
respective pins 71 and 72 at the opposite ends of the link 70. FIG.
7 also illustrates the slider pin 72 urged against the actuator
spring 76. The spring 76 is disposed within a compartment of the
slider 28. The opposite end of the actuator spring 76 is retained
by means of a retaining pin 80 that is disposed in the bore 78 that
accommodates the spring 76. FIGS. 6, 7 and 19 also show the return
spring 82 which is disposed within a bore 84 in the handle for
accommodating the spring 82. One end of the spring 82 is urged
against an interior wall of the handle and the opposite end of the
spring is urged against an end wall of the slider 28. The spring 76
is a stronger spring than the spring 82 so that the spring 82
compresses first as the lever 22 is activated. Additional motion of
the lever then causes the spring 76 to compress as the item is
grasped. This dual spring arrangement prevents damage to the
instrument cabling, particularly at the distal end of the
instrument due to excessive forces imposed by the lever action.
[0069] The lever 22 actuates the end effector as it is pressed
toward the handle body. The lever 22 operates with a ratchet and
pawl arrangement with the lever capable of being depressed in
ratcheted increments. This ratchet and pawl arrangement includes
the ratchet 86 and pawl 88. To accommodate the ratchet 86, the
slider 28 is provided with an end dish out or cut out 87, such as
is illustrated in FIG. 5. The pawl 88 depicted also in FIG. 19 is
retained by the handle members 12A and 12B. In this regard in
handle part 12A there is a pocket 89 for the pawl 88 and in the
handle part 12B there is provided a leg 89A for retaining the pawl.
The ratchet 86 pivots at the pivot pin 90 and is provided with a
series of ratchet teeth that can hold the ratchet in successive
positions corresponding to successive degrees of closure of the end
effector. A torsion spring 92 is disposed partially about the pivot
90 and urges the ratchet teeth into contact with the pawl 88 as
illustrated in FIG. 7 in a fully closed position.
[0070] The ratchet and pawl arrangement also includes an integral
release means that is usually engageable by the surgeons thumb. As
depicted in FIG. 7, on one side of the pivot 90 there is the
ratchet 86 and on the other side of the pivot there is the arm 94.
A release button 96 is formed at the base of the arm 94. When a
force is directed in the direction of arrow M in FIG. 7 then this
releases the ratchet and pawl arrangement and returns the lever 22
to its released position with the jaws fully opened, as in FIG.
5.
[0071] Reference is now made to the cabling that extends between
the proximal and distal bendable members. This cabling is provided
so that any bending at the proximal bendable member is converted
into a corresponding bending at the distal bendable member. The
bendable members that are described herein enable bending in all
directions. In the preferred embodiment described herein, the
distal bendable member is approximately 1/3 the diameter of the
proximal bendable member as illustrated in FIG. 5. However, as
indicated before other diameter relationships can be used depending
upon the particular use of the instrument and the medical procedure
in which it is being used.
[0072] The control between the proximal bendable member 18 and the
distal flexible member 20 is carried out by means of the flex
control cables 100. There are four such cables identified, for
example, in FIG. 21 as cables 100A, 100B, 100C and 100D. At the
distal end of these cables, as has been described hereinbefore, the
cables connect to the anchors 56 and 58 at the jaws. Cables 100 are
retained at their proximal ends by cable end lugs 102. Four springs
104 are retained between these end lugs 102 and a wall of the
rotation knob 24. Refer to FIG. 19 for an illustration of the end
lugs 102 and the springs 104. The springs 104 tension or take up
the slack on the cables. Between the bendable members, the cables
100 are guided by means of the slots 37 in the spacers 36 along the
support tube 34. Refer also to FIGS. 23 and 24. Within the adaptor
cover 26, the cables 100 extend through the transition member 106.
The cables then extend to a larger outer diameter locus as they
extend through the proximal bendable member as depicted in FIGS. 6
and 7. The stepped transition member 106 may be of metal and is
secured to the end of tube 32.
[0073] FIG. 21 depicts the distal end of the instrument and, in
particular, the distal flexible member 20. This is in the form of a
single piece slotted structure comprised of alternating slots and
discs. The discs are supported from a central member defining the
bore 120. FIGS. 21 and 22 illustrate the discs 110 that define
therebetween the annular slots 112. Between adjacent discs there
are also provided connecting ribs 111. Clearance holes 114 are
provided for receiving the cables 100. These clearance holes are
provided in the ribs and discs. To align the distal flexible member
with the shaft tube 32, there is provided an alignment tab 116 on
the distal bendable member 20 and a corresponding slot 118 in the
tube 32. One tab and slot arrangement is illustrated in FIG. 21,
however, it is understood that more than one tab and slot may be
provided The distal bendable member 20 also has a central bore 120
for receiving the aforementioned PEEK tube 60.
[0074] The proximal bendable member 18 is also constructed as a
unitary or uni-body slotted structure including a series of
flexible discs 130 that define therebetween slots 132. A "unitary"
or "uni-body" structure may be defined as one that is constructed
for use in a single piece and does not require assembly of parts.
Connecting ribs 131 extend between the discs. Clearance holes 134
are provided for accommodating the cables 100. As with the distal
bendable member, the proximal bendable member also includes
alignment tabs 136 and corresponding slots (not shown) in the
rotation knob 24. The proximal bendable member 18 is also provided
with a central bore 140 for receiving the tube 62
[0075] Both of the bendable members preferably have a rib pattern
in which the ribs (111, 131) are disposed at a 60 degree variance
from one rib to an adjacent rib. This has been found to provide an
improved bending action. It was found that by having the ribs
disposed at intervals of less than 90 degrees therebetween improved
bending was possible. The ribs may be disposed at intervals of from
about 35 degrees to about 75 degrees from one rib to an adjacent
one. By using an interval of less than 90 degrees the ribs are more
evenly distributed. As a result the bending motion is more uniform
at any orientation. In the present invention both of the bendable
members may be made of a highly elastic polymer such as PEBAX
(Polyether Block Amide), but could also be made from other elastic
materials.
[0076] FIGS. 5-7 illustrate a sequence of operation of the surgical
instrument, including in particular the tool actuation that is
controlled by the actuation lever 22. In the illustrated example
employing a pair of jaws, there is provided a dual spring
arrangement (springs 76 and 82) that enables the grasped item to be
securely held by the jaws. Reference is now made to FIG. 5 for an
illustration of the surgical instrument in which the lever 22 is at
its fully released (down) position corresponding to the jaws 44 and
46 being in a fully open position. At any time the release button
96 may be depressed to move the lever 22 to that position. In that
position the springs 76 and 82 are in their expanded or relaxed
position and the ratchet 86 is at its top end of travel with the
pawl engaging a top tooth of the ratchet.
[0077] The cross-sectional view of FIG. 6 illustrates the lever 22
being depressed further. This is illustrated by the arrow H in FIG.
6. The depression of the lever 22 causes a corresponding motion of
the link 70. This motion imparts a force to the spring 72. However,
spring 76 is a stiffer spring than spring 82 and thus in the
position illustrated in FIG. 6 the slider pin 72 is maintained to
the left of the slot 74. At the position of FIG. 6 substantially
only the larger diameter spring 82 is compressed. This is
illustrated by the arrow I. In this position it is also noted that
the ratchet has now moved to a position approximately mid-point of
its teeth at ratchet 86 relative to the pawl 88. This action
represents the state where the jaws are just beginning to exert a
force on the needle. This is illustrated by the arrow J in FIG. 6,
indicating movement of the jaws to a more closed position for
grasping the needle 45.
[0078] At the position illustrated in FIG. 6, the spring 82, having
a smaller poundage than the spring 76, compresses when the force on
the lever is approximately 3 to 4 pounds. In the position of FIG.
6, even though the needle 45 has been grasped, the spring 76 is
substantially non-compressed at that stage, but is pre-loaded from
the spring 82.
[0079] Reference is now made to FIG. 7 for an illustration of the
lever 22 having been moved to a position in which the spring
pressure imposes a tightening of the item that is being grasped. In
FIG. 7 the arrow K illustrates the further lever movement loading
the spring pressure on the jaws. This additional lever rotation
causes the slider pin 72 to slide within the slot 74 further
compressing the spring 76. This is illustrated in FIG. 7 by the
arrow L. This imposes an additional force on the slider 28 causing
the actuator cable 38 to tightly close the jaws about the needle
45. FIG. 7 also illustrates by the arrow M the release sequence in
which the button 96 may be pressed to release the ratchet 86 from
the pawl 88 and thereby return the lever arm 22 to the position
illustrated in FIG. 5.
[0080] Reference is now made to FIGS. 9-18. These figures are
successive cross-sectional views taken from FIG. 6 and showing
further cross-sectional details of components of the surgical
instrument. The cross-sectional view of FIG. 8 is a longitudinal
cross-section illustrating the top of the slider 28. The
cross-sectional view of FIG. 9 is taken at the jaws 44 and 46 and
further illustrates the slide pin 42 controlled to move in the
slots 50 and 52 by engagement with the distal cable end connector
40.
[0081] The cross-sectional view of FIG. 10 illustrates the anchors
56 and 58 for the flexible cables as well as the tool actuator
cable 38 disposed within the tube 60.
[0082] FIG. 11 is a cross-sectional view taken through the distal
bendable member 20. FIG. 11 also illustrates the actuator cable 38,
tube 60 and the position of the ribs 111. It is apparent from FIG.
11 that the ribs 111 are disposed, from one to the other, at an
angle of approximately 60 degrees. These ribs are preferably
disposed at an angle of less than 90 degrees.
[0083] FIG. 12 is a cross-sectional view taken through the
instrument shaft. This view illustrates the support tube 34 having
the actuator cable 38 therein. This view also illustrates the outer
shaft tube 32 and the flex control cables 100.
[0084] FIG. 13 is a cross-sectional view taken at the adaptor cover
26 where the control cables transition between the instrument shaft
and the proximal bendable member 18. FIG. 13 illustrates the four
flex control cables 100A, 100B, 100C and 100D so transitioning.
FIG. 13 also illustrates one of the spacers 36 with its associated
guide slots.
[0085] FIG. 14 is a cross-sectional view taken directly through the
proximal bendable member 18. This illustrates the disks 130 and the
interconnecting ribs 131. Clearance holes 134 are illustrated for
receiving the control cables 100. As with the distal bendable
member, the proximal bendable member has its ribs disposed at 60
degree intervals from one rib to the next. These ribs are
preferably disposed at an angle of less than 90 degrees. The
clearance holes 134 are preferably diametrically disposed as
illustrated in FIG. 14. FIG. 14 also illustrates the angular
relationship between the ribs as angle .theta., and the
interrelationship regarding the clearance holes as the angle
.beta.. The angle .beta. is shown at 90 degrees.
[0086] FIG. 15 is a further cross-sectional view that is taken
essentially at the proximal end of the rotation knob 24. This
illustrates the cable end lugs 102, the actuation cable 38 and the
rotation shaft 64. It is also noted in FIG. 15 that the same arrows
are used therein as previously described in connection with FIG. 4.
Thus, in FIG. 15 the arrow R1 indicates rotation of the knob 24
while the arrow R2 indicates rotation of the instrument shaft. The
rotation knob 24, as illustrated, includes a plurality of
indentations 24A. These are preferably arcuate as shown and define
therebetween peaks 24B. This surface is configured so that the
thumb of the user can readily rotate the knob 24 by engagement of
the thumb with one or more of the knob indentations 24A.
[0087] The cross-sectional view of FIG. 16 illustrates the ratchet
and pawl locking action for the spring tensioning of the actuator
cable 38. FIG. 16 illustrates the ratchet 86, the pawl 88, the
release button 96, the torsion spring 92, and the rotation shaft 64
with its associated E-ring 65. FIG. 16 also illustrates the release
button 96.
[0088] FIG. 17 is a cross-sectional view showing the rotating
barrel means that is used to prevent torsional forces on the
actuator cable 38. The slider 28 has a pocket 68 for accommodating
the rotational barrel 66. FIG. 17 also shows a set screw 67 for
attaching the actuator cable 38 to the rotational barrel 66.
[0089] Finally, the cross-sectional view of FIG. 18 shows further
details of the spring loading means. This includes the spring 76,
slider 28, lever 22, and link 70.
[0090] Reference is now made to FIG. 22. FIG. 22 is a
cross-sectional view that focuses on the proximal and distal
bendable members particularly as to the relationship between the
bending angles that are preferred. Regarding the proximal bendable
member 18, this is illustrated as being bent through an angle B1.
The distal bendable member 20 is illustrated as being bent through
an angle B2. By way of example, the angle B1, if at a 35 degree,
corresponds with a distal bendable angle B2 of approximately 70
degrees. Thus, it can be seen that the difference in diameter
between the bendable members enables a greater degree of bending at
the distal end for a corresponding bending at the proximal end.
Although this illustrated diameter relationship for the bendable
members is preferred, it should be understood that other variations
may be used, including the use of the same diameters at the
proximal and distal ends of the instrument or even using a larger
diameter at the distal end corresponding to a smaller diameter at
the proximal end.
[0091] Reference is now made to the schematic diagrams of FIGS. 23
and 24. The schematic diagram of FIG. 23 corresponds to the
instrument motions depicted in FIGS. 3a-3c. The schematic diagram
of FIG. 24 corresponds to the instrument motions depicted in FIGS.
2a-2c. In FIG. 23 the instrument shaft 14 is illustrated as
containing a series of spacers 36 having associated guide slots 37
for positioning each of the control cables 100. In this embodiment
the control cables extend in a straight orientation while in FIG.
24 the control cables are twisted through 180degrees.
[0092] In FIG. 23 at the distal end of the instrument, the control
cables are identified as cables 100A, 100B, 100C and 100D. At the
proximal end of the instrument, the same cables are identified as
cables 100A', 100B', 100C' and 100D'. This straight alignment of
the cables results in a relationship between the proximal and
distal bendable members as illustrated in FIGS. 3a-3c. In other
words, when the handle end is moved up the tool end moves down and
vice versa. In the schematic diagram of FIG. 24, the same number of
spacers 36 may be employed. In an actual instrument that has been
constructed five such spacers have been used, although, for
simplicity in FIGS. 23 and 24 only three spacers are shown. In the
embodiment of FIG. 24 the control cables 100 are twisted 180
degrees as they progress from one end of the instrument shaft to
the other. Thus, for example, a proximal cable 100C' at the
proximal end of the instrument is twisted so that the cable 100C at
the distal end of the instrument is displaced by 180 degrees. This
creates a related bending between the proximal end distal ends of
the instrument as is illustrated in FIGS. 2a-2c. In other words,
when the handle end is moved up the tool end moves up and vice
versa.
[0093] Regardless of which embodiment is used, either the one in
FIG. 23 or the one in FIG. 24, the actuator cable 38 operates in
substantially the same way. Operation of the lever 22 pulls the
cable in a direction of arrow I in FIG. 6, closing the end
effector. Release of the lever moves the cable in the opposite
direction. Both actions occurs in the normal position of the
instrument such as in FIG. 3a or in other deflected positions such
as in FIGS. 3b and 3c where the proximal bendable member 18
controls the distal bendable member 20. In this regard, the cable
38 is preferably supported centrally in the instrument shaft as
well as in the bendable members as illustrated in the drawings
herein. In this way, when a bending occurs there is no significant
movement imparted to the cable 38 by the bending action. In other
words, the end effector actuation is de-coupled from the bending
action.
[0094] The rotation of the knob 24 also occurs without effecting
the bending and tool actuation actions. This rotation action is
also de-coupled from these other actions or motions. For example,
rotation of the knob 24, in and of itself, does not effect tool
actuation or bending actions. Regardless of the position of the
lever 22 or the degree of bending at the proximal bendable member,
any rotation at the knob 24 imparts a like rotation to all of the
components distal of the knob 24 including the instrument shaft 14,
the end effector 16 and the proximal and distal bendable members 18
and 20 while maintaining the orientation at the distal end bendable
section. As the components are rotated from the knob 24, the cable
38 will rotate therewith. The rotating barrel means, namely the
barrel 66, prevents torsional forces on the tool actuator cable.
The rotational barrel 66, which is secured to the very proximal end
of the actuator cable 38, is rotatable within the slider 28 so that
the cable readily rotates with the rotation of the knob 24. It is
noted that the direction of the bend (orientation) of the distal
bendable member is not effected by the rotation at the knob 24.
This rotation simply rotates the distal motion member on its own
axis without changing orientation.
[0095] Another aspect of the surgical instrument of the present
invention relates to the ease with which the surgeon can manipulate
the instrument in effectively performing a surgical procedure. The
placement of the rotation knob 24 in close proximity to the handle
12 and proximal bendable member 18 makes manipulation easier. It is
advantageous to have a part of the proximal bendable member 18
disposed within a hollow center of the rotation knob 24 as is
clearly shown in FIGS. 6 and 7. The hollow area is formed by a
tapered wall 25 (see FIGS. 7 and 22) that enables bending or
deflection of the proximal bendable member 18, such as is
illustrated in FIG. 22 where the proximal bendable member 18 is at
one extreme of bending. The knob 24 is also shown rotationally
supported adjacent to the handle 12 so that it is in a convenient
position for use by the surgeon.
[0096] The axial rotation knob 24 is rotatably mounted on the tube
64, which in turn is clamped to the handle body. As a result the
axial rotation knob is able to freely rotate relative to the handle
body, manipulated by either the thumb or index finger, instead of
rotating the entire handle assembly. The axial rotation knob 24 has
the tapered or conical cavity in which the proximal bendable member
is mounted for motion with the knob. In order to maintain maximum
control of the distal tool, the proximal bendable member is
disposed at least partially within the conical cavity in the axial
rotation knob 24 thereby minimizing the distance between the knob
and the user's hand. If the proximal bendable member is situated
too far from the handle this can give the user a feeling of
floppiness in the use of the instrument. Accordingly, by disposing
the proximal bendable member at least partially within the knob one
minimizes this sloppiness. This placement also enables the
instrument shaft to be closer to the user's hand. There may be
instances where the user wants to control the instrument by
directly applying pressure to the instrument shaft rather than
through the bendable member. In such case the user would lean their
index finger on the finger support sleeve 26 which would allow the
user to apply force directly on the instrument shaft.
[0097] As indicted hereinbefore and as depicted in FIG. 4 the
surgeon is able to roll the instrument's tool about its
longitudinal axis at any orientation (bent position) simply by
rolling the axial rotation knob 24. FIGS. 25-28 illustrate the
sequential positions of the rotation knob 24 and the corresponding
orientation of the tool 16, rotated about the tool axis P. The
direction or orientation of the bend (angle B2) of the distal
bendable member, relative to the shaft axis Z, is not effected by
the rotation at the knob 24. As can be seen from the sequence of
FIGS. 25-28, this rotation simply rotates the distal motion member
and tool on its own distal motion axis P without changing the
orientation of the tool. The orientation is only affected by the
bending action.
[0098] The instrument schematically illustrated in FIGS. 25-28 may
be the same instrument as described hereinbefore in FIGS. 1-24. In
FIGS. 25-28 the bendable members are considered as being maintained
in a particular position corresponding to the same respective
proximal and distal bendable member angles B1 and B2. The
respective FIGS. 25-28 show the rotation knob 24 in successive 90
degree positions and the manner in which the motion imparted to the
rotation knob is transferred to the distal bendable member and
tool. From position to position the orientation of the tool along
axis P is maintained the same. In one example in FIGS. 25-28 the
angle B1 may be 25 degrees and the angle B2 may be 35 degrees. The
angle B1 is measured between axis T of the handle and the main
instrument axis Z, while angle B2 is measured between the distal
tool axis P and the axis Z.
[0099] The control between the proximal bendable or flexible member
18 and the distal bendable or flexible member 20 is carried out by
means of the flex control cables 100. There are four such cables
identified as cables 100A, 100B, 100C and 100D. At the distal end
of these cables, as has been described hereinbefore, the cables
connect to the anchors 56 and 58 at the jaws. Cables 100 are
retained at their proximal ends by cable end lugs 102. Four springs
104 are retained between these end lugs 102 and a wall of the
rotation knob 24. FIGS. 25-28 illustrate the cable ends by the
proximal ends 100A', 100B', 100C' and 100D', and by the distal ends
100A'', 100B'', 100C'' and 100D''.
[0100] FIG. 25 also depicts the rolling motion that can be carried
out with the instrument of the present invention. This occurs by
virtue of the rotation of the rotation knob 24 relative to the
handle 12 about axis T. This is illustrated in FIG. 25 by the
circular arrow R1. When the rotation knob 24 is rotated, in either
direction, this causes a corresponding rotation of the instrument
shaft 14 about axis Z. This is depicted in FIG. 25 by the
rotational arrow R2. This same motion also causes a rotation of the
end effector 16 about axis P as illustrated by the rotational arrow
R3. FIGS. 25-28 also show a proximal coordinate at Q at the
proximal cable ends and a distal coordinate at U at the distal
cable ends. The directional arrows N(north); W(west); S(south) and
E(east) depict the sequential rotation of the rotation knob 24 in
these coordinate systems, and as relates to the state of the
cabling between the proximal and distal members of the
instrument.
[0101] FIG. 25 depicts an initial position of the instrument with
the bendable members 18 and 20 in a certain position. For the sake
of clarity in describing the operation the bendable members are
considered as being maintained in the same bent condition and only
the knob rotation is considered as changing during the sequence
from FIG. 25 to FIG. 28. Of course, in practice the instrument
functions with the ability to bend in any direction and to roll the
tool about axis P through any angle in performing an actual medical
procedure. Also, even though only 90 degree intervals are described
in relationship to FIGS. 25-28, it is understood that the same
distal rotation about axis P occurs for all intermediate positions.
Also, four cables are depicted in the illustrated embodiments,
however, fewer or more then four may be used
[0102] In FIG. 25 the handle 12, via proximal bendable member 18,
is shown tilted along axis T at an angle B1. This tilting or
bending may be considered as in the plane of the paper. By means of
the cabling 100 this action causes a corresponding bend at the
distal bendable member 20 to a position wherein the tip is directed
along axis P and at an angle B2. This distal bending is also
considered as in the plane of the paper. The cabling 100 is
depicted wherein two of the cables are considered in tension and
the other two are relaxed. In the position depicted the rotation
knob 24 may be considered as in the initial position N. In that
position the cables 100A and 100B are in their relaxed state while
cables 100C and 100D are in their tensioned state. This causes a
bending down of the instrument tip in response to the handle being
bent or pivoted upwardly, as shown.
[0103] The rotation knob 24 is then rotated through 90 degrees to
the position W depicted in FIG. 26. This rotates the position of
the cables so that the cables 100B and 100C are in their relaxed
state while cables 100A and 100D are in their tensioned state. This
action maintains the same orientation of the tool 16 along axis P,
but rotates the distal bendable member and tool about the axis P.
Both ends of the instrument are maintained in the plane of the
paper. The rotation of the tool is depicted by the jaws having been
rotated through 90 degrees, as can be seen by a comparison of FIGS.
25 and 26. The orientation along axis P is maintained.
[0104] The rotation knob 24 is then rotated through 90 degrees to
the position S depicted in FIG. 27. This rotates the position of
the cables so that the cables 100C and 100D are in their relaxed
state while cables 100A and 100B are in their tensioned state. This
action maintains the same orientation of the tool 16 along axis P,
but rotates the tool about the axis P. Both ends of the instrument
are maintained in the plane of the paper. The rotation of the tool
is depicted by the jaws having been rotated through 90 degrees, as
can be seen by a comparison of FIGS. 26 and 27. The orientation
along axis P is maintained.
[0105] The rotation knob 24 is then rotated through 90 degrees to
the position E depicted in FIG. 28. This rotates the position of
the cables so that the cables 100A and 100D are in their relaxed
state while cables 100B and 100C are in their tensioned state. This
action maintains the same orientation of the tool 16 along axis P,
but rotates the tool about the axis P. Both ends of the instrument
are maintained in the plane of the paper. The rotation of the tool
is depicted by the jaws having been rotated through 90 degrees, as
can be seen by a comparison of FIGS. 27 and 28. The orientation
along axis P is maintained.
[0106] In the disclosed embodiments the rotation knob is
illustrated as a knob having indentations for the finger or
fingers. In alternate embodiments of the invention the rotation
function may be performed by other means such as a rotation wheel
or a rotatable lever.
[0107] Still another aspect of the surgical instrument of the
present invention is the ability to adapt the instrument to a wide
variety of medical procedure. This includes, but is not limited to,
access to a body cavity such as through an incision or intraluminal
use such as through a natural body aperture to a body lumen. The
introduction of the surgical instrument into the anatomy may also
be by percutaneous or surgical access to a lumen, cavity or vessel,
or by introduction through a natural orifice in the anatomy.
[0108] There are several improvements brought forth by employing
bendable sections for the motion members particularly as opposed to
other mechanisms such as pivotal joints or ball-and-socket
joints.
[0109] A first important attribute of a bendable member is in its
inherent lateral (bending) stiffness, especially when used for the
proximal handle motion member. In a jointed arrangement the
proximal joint is situated between the elongated shaft and the
control handle, together with the fulcrum at the incision. This
behaves as a "double joint" and the instrument may have a serious
tool stability issue if the joint is "free" to move. Suppose the
operating surgeon slightly moves his/her wrist while holding the
control handle of the instrument. If the joint is "free" to move
without providing substantial support resistance, due to the
fulcrum effect of the long elongated shaft passing through the
incision, it will result in substantial, unintended swinging of the
tool end of the instrument in opposite direction. In a typical
laparoscopic or endoscopic procedure where the operating field is
small, such instability of the tool will render the tool
potentially dangerous and unusable. Unlike the pivotal or
ball-and-socket joints that are "free" to move, a bendable member
has inherent stiffness which acts to provide necessary support for
stabilizing the operator hand's wrist movement, which in turn
stabilizes the tool motion. By varying the material and geometry of
the bendable member, the appropriate level of stability could be
selected.
[0110] A second important attribute of the bendable member,
especially for bending in two degrees of freedom, is its uniformity
in bending. Because the bendable member can bend in any direction
uniformly, it has no inherent singularity, and as the result, the
operator can produce uniform rolling motion of the tool, an
important motion for tasks such as suturing, simply by rolling the
control handle. On the other hand, if the motion members are
comprised of series of pivotal joints, not only may it bind due to
singularities, but the rolling of the control handle will result in
unwanted side motion of the tool as well, affecting its usability
for surgical procedure.
[0111] A third attribute of the bendable member is its ability to
transmit substantial torque axially. By selecting appropriate
material and geometry, the bendable member can be constructed to
transmit torque axially necessary to perform surgical procedure. On
the other hand, the motion member comprised of ball-and-socket
joints will not be able to transmit the necessary torque from the
handle to the tool end.
[0112] A fourth attribute of the bendable member is that it has no
sharp bending point, location or pivot and thus this results in an
increased life and higher performance. Either pivotal or
ball-and-socket joints on the other hand have sharp corners which
can increase friction, reduce life and decrease performance of the
tool actuation push rod passing through.
[0113] A fifth attribute of the bendable member is in the reduction
of manufacturing cost. The bendable motion member can be injection
molded as a single body, thus significantly reducing the cost.
Pivotal or ball-and-socket joints are comprised of more parts and
this results in a higher manufacturing cost.
[0114] Lastly, a sixth attribute of the bendable member is that it
can be easily customized. By varying the stiffness at different
points of the bendable member, one can optimize its bending shape
for specific applications.
[0115] While this invention has been particularly shown and
described with references to preferred embodiments thereof, it will
be understood by those skilled in the art that various changes in
form and details may be made therein without departing from the
scope of the invention encompassed by the appended claims. For
example, the embodiments described herein have primarily used four
control cables for providing all direction motion of the motion
members. In alternate embodiments fewer or greater numbers of
cables may be provided. In a most simplified version only two
cables are used to provide single DOF action at the bendable motion
member. Also, the disclosed embodiment uses a handle that is
essentially in line with the instrument shaft. In an alternate
embodiment of the invention the handle can be off axis or at an
angle to the instrument shaft in the rest position of the
instrument.
* * * * *